Short-term use of foot orthoses reduces pain and disability in elderly women with osteoporosis, results of a randomized clinical trial indicate.
Orthoses worn for 4 weeks also improved balance in this fracture-prone population, suggesting that insoles may be an adjuvant strategy to prevent falls in the elderly.
The trial included 94 women with osteoporosis aged 60 years and older (median age 72.38 years) who were randomly assigned to wear an orthosis or not for 4 weeks. The orthoses were custom-made for each patient from ethylene-vinyl acetate and featured a medial arch support and a metatarsal pad.
At 4-week follow up, the group assigned to wear orthoses showed significant improvements versus baseline in each of the study's four endpoints - the Berg Balance Scale (from 43.30 to 50.68), the Timed Up and Go test (from 15.16 to 11.97), the Manchester Foot Pain and Disability Index (from 20.98 to 11.48), and a numeric pain scale (from 3.43 to 1.68).
By contrast, in the control group, average scores on the numeric pain scale increased significantly (from 3.76 to 4.20) while the other three endpoints were unchanged at 4 weeks versus baseline.
Interestingly, there was evidence of a dose-response effect, whereby patients who wore their insoles for more than 8 hours per day experienced a significantly greater improvement in balance over the study period than those who wore them for less than 4 hours per day.
Furthermore, the orthoses were generally well tolerated, with just one patient discontinuing due to pain. Six patients reported minor adverse effects such as discomfort, foot heat, and tightness of footwear, and there were no falls in either group during the study period.
The improvements in pain, disability, and balance in the orthosis group were independent of sociodemographic and clinical factors, such as age, race, education, marital status, body mass index, age of menopause, medication use, visual or hearing complaints, number of falls, and previous fractures.
Writing in Rheumatology, Eduardo de Paiva Magalhães (State University of Campinas, Brazil) and co-authors note that balance impairment is common in the elderly and is associated with an increased risk for falls and fractures.
"Elderly plantar somatosensorial impairment and poorer central postural integrative mechanisms seem to have an important effect on balance," they note.
While admitting that their study has some limitations, the researchers nevertheless say the results "strongly suggest that insoles with medial arch support and metatarsal pad are effective for improving balance in a high-fracture risk group."
They add: "Studies regarding the mechanisms of action of insoles that provide information about the various possible devices that can be used and the most suitable plantar regions to place them should be encouraged."
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